NCT06019702招募中1 期
A Clinical Study to Assess the Safety, Feasibility, and Efficacy of Personalized mRNA Vaccine Encoding Neoantigen Alone in Subjects With Advanced Digestive System Neoplasms
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Receiving iNeo-Vac-R01 Injection Treatment to Enrolled Subjects [feasibility]
研究概览
简要总结
The purpose of this study is to assess the safety, feasibility, and efficacy of personalized mRNA vaccine iNeo-Vac-R01 alone in subjects with advanced digestive system neoplasms.
详细描述
This is a multi-part single-center, open-label, single-arm clinical study of personalized mRNA vaccine iNeo-Vac-R01 monotherapy in subjects with advanced digestive system neoplasms. The study will include a dose escalation phase and dose expansion phase. The traditional 3+3 design will be used in dose escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, >/= 18 years old and </= 75 years old, with the ability to understand and provide signed and witnessed informed consent, and agree and are able to comply with protocol requirements.
- •Subjects must have one of the histologically- or cytologically-confirmed advanced (locally advanced or metastatic) digestive system neoplasms, have measurable disease at study entry defined by RECIST v1.
- •Subjects must have tumor progression after standard treatment or are intolerant or are unwilling to receive standard treatment. The toxic effects of previous anti-tumor treatments have returned to </= grade 1 defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 or to the level specified by the inclusion/
排除标准
- •3. Expected survival \>/= 6 months.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 \~ 2.
- •5. Sufficient tumor tissue samples can be obtained from subjects for genetic analysis, with at least 2 puncture tissues with a tumor purity of ≥ 50% required for puncture samples and at least 0.5cm of tissue required for surgical samples. Alternatively, the original gene sequencing data required for tumor neoantigen analysis can be provided, including full exon sequencing data of tumor tissue, transcriptome sequencing data, and full exon sequencing data of peripheral blood.
- •6. Echocardiographic evaluation: left ventricular ejection fraction (LVEF) \>/= 50%.
- •7. The organ function level must meet the following requirements: absolute neutrophil count (ANC) \>/= 1.5 × 10\^9/L, platelet count (PLT) \>/= 80 × 10\^9/L, hemoglobin (Hb) \>/= 90 g/L; serum total bilirubin (TBIL) \/= 28g/L, serum creatinine \/= 50mL/min, prothrombin time (PT) and activated partial thromboplastin time (APTT) and international standardized ratio (INR) \/= grade 3, heart failure within 8 weeks before the first dose of iNeo-Vac-R01 (New York Heart Association \[NYHA\] cardiac function \>/= grade II, myocardial infarction, unstable angina, stroke, transient ischemic attack, cardiac surgery (including coronary artery bypass grafting or percutaneous coronary intervention) within 8 weeks before the first dose of iNeo-Vac-R01, concomitant severe electrocardiogram abnormalities (such as ventricular flutter, ventricular fibrillation, multiform ventricular tachycardia, sick sinus syndrome, third degree atrioventricular block without pacemaker treatment, QTc \>/= 480ms, and other conditions evaluated by the investigators as severe abnormalities), hypertension with poor drug control (systolic blood pressure \>/= 160mmHg and/or diastolic blood pressure \>/= 100mmHg), or other cardiocerebrovascular diseases that have been evaluated by the investigators as unsuitable for participation in this trial.
- •12. Subjects with respiratory disease: previously or currently pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe asthma, pulmonary hypertension or severe impairment of lung function, etc.
- •13. Subjects with moderate to severe ascites with clinical symptoms; uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.
- •14. Subjects with drug abuse; clinical or psychological or social factors that affect informed consent or research implementation.
- •15. Subjects with a history of allergies to immunotherapy or vaccines, or other potential immunotherapy allergies identified by the investigators.
- •16. Subjects identified that it is not suitable for enrollment or may not be able to complete this experiment for other reasons by the investigators.
- •17. Vulnerable groups, including individuals with mental illness, cognitive impairment, critical patients, minors, pregnant or lactating women, etc.
研究组 & 干预措施
Personalized mRNA Vaccine iNeo-Vac-R01
Experimental
The traditional 3+3 design will be used in dose escalation. In dose escalation phase, subjects are expected to be enrolled at 50 μg, 100 μg and 150 μg (3-6 subjects in each group). The low dose group will be enrolled first. Subjects will receive iNeo-Vac-R01 administered via a hypodermic (IH) injection on Day 1 of each 21-day cycle for up to 9 cycles. The investigators will choose the optimal clinical dose for dose expansion phase.
干预措施: iNeo-Vac-R01 (Biological)
结局指标
主要结局
Proportion of Subjects Receiving iNeo-Vac-R01 Injection Treatment to Enrolled Subjects [feasibility]
时间窗: 21 days after last iNeo-Vac-R01 dose
Dose-limiting Toxicity (DLT)
时间窗: 28 days (+/-3 days) after first iNeo-Vac-R01 dose
Level 3 or 4 AEs related to iNeo-Vac-R01 injection.
Number of Participants with Adverse Events (AEs) [safety and tolerability]
时间窗: 21 days after last iNeo-Vac-R01 dose
次要结局
- Overall Survival (OS)(3 years after first dose of iNeo-Vac-R01)
- Objective Response Rate (ORR)(3 years after first dose of iNeo-Vac-R01)
- Disease Control Rate (DCR)(3 years after first dose of iNeo-Vac-R01)
- Duration of Response (DOR)(3 years after first dose of iNeo-Vac-R01)
- Part A and Part B: Progression Free Survival (PFS)(3 years after first dose of iNeo-Vac-R01)
- T Cell Subsets [immunogenicity](12 months after first dose of iNeo-Vac-R01)
- Cytokines Level [immunogenicity](6 months after first dose of iNeo-Vac-R01)
- Neoantigen-specific T Cell Response [immunogenicity](12 months after first dose of iNeo-Vac-R01)
研究者
Xiujun Cai
The director of Sir Run Run Shaw Hospital
Sir Run Run Shaw Hospital
研究点 (1)
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